FDA approves Genvoya
The U.S. Food and Drug Administration (FDA) has approved Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Although Genvoya has efficacy comparable to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate or E/C/F/TDF), the tenofovir alafenamide (TAF) combination demonstrated an improved safety profile compared to the tenofovir disoproxil fumarate (TDF) combination in clinical trials.
Important information
Genvoya can cause serious side effects, including:
Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis may happen in some people who take Genvoya. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
feel very weak or tired
have unusual (not normal) muscle pain
have trouble breathing
have stomach pain with
nausea
vomiting
feel cold, especially in your arms and legs
feel dizzy or lightheaded
have a fast or irregular heartbeat
Severe liver problems. Severe liver problems may happen in people who take Genvoya. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis).
Call your healthcare provider right away if you get any of the following symptoms of liver problems:
your skin or the white part of your eyes turns yellow (jaundice)
dark tea-colored urine
light-colored bowel movements (stools)
loss of appetite for several days or longer
nausea
stomach pain
You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking Genvoya for a long time.
Worsening of Hepatitis B infection. Genvoya is not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B virus (HBV) infection and take Genvoya, your HBV may get worse (flareup) if you stop taking Genvoya. A flare-up is when your HBV infection suddenly returns in a worse way than before.
Do not run out of this medicine. Refill your prescription or talk to your healthcare provider before your Genvoya is all gone.
Do not stop taking this medicine without first talking to your healthcare provider.
If you stop taking Genvoya, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop treatment.
Genvoya is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older:
who have not received anti-HIV-1 medicines in the past, or
to replace their current anti-HIV-1 medicines:
in people who have been on the same anti-HIV-1 medicine regimen for at least 6 months, and
who have an amount of HIV-1 in their blood (this is called viral load) that is less than 50 copies/mL, and
have never failed past HIV-1 treatment.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Genvoya contains the prescription medicines elvitegravir (Vitekta), cobicistat (Tybost), emtricitabine (Emtriva) and tenofovir alafenamide.
It is not known if Genvoya is safe and effective in children under 12 years of age.
When used to treat HIV-1 infection, Genvoya may:
Reduce the amount of HIV-1 in your blood. This is called viral load.
Increase the number of CD4+ (T) cells in your blood that help fight off other infections.
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
Genvoya does not cure HIV-1 infections or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others.
Do not share or re-use needles or other injection equipment.
Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions about how to prevent passing HIV-1 to other people.
Do not take Genvoya if you also take a medicine that contains:
alfuzosin hydrochloride (Uroxatral)
carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR, Teril)
cisapride (Propulsid, Propulsid Quicksolv)
ergot-containing medicines, including:
dihydroergotamine mesylate (D.H.E. 45, Migranal)
ergotamine tartrate (Cafergot, Migergot, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes)
methylergonovine maleate (Ergotrate, Methergine)
lovastatin (Advicor, Altoprev, Mevacor)
midazolam, when taken by mouth
phenobarbital (Luminal)
phenytoin (Dilantin, Phenytek)
pimozide (Orap)
rifampin (Rifadin, Rifamate, Rifater, Rimactane)
sildenafil (Revatio), when used for treating the lung problem, pulmonary arterial hypertension (PAH)
simvastatin (Simcor, Vytorin, Zocor)
triazolam (Halcion)
St. Johns wort (Hypericum perforatum) or a product that contains St. Johns wort
Before taking Genvoya, tell your healthcare provider if you:
have liver problems, including hepatitis B infection
have kidney problems
have bone problems
have any other medical
conditions
are pregnant or plan to become pregnant. It is not known if Genvoya can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.
Pregnancy registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
are breastfeeding or plan to breastfeed. Do not breastfeed if you take Genvoya.
You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
At least one of the medicines in Genvoya can pass to your baby in your breast milk. It is not known if the other medicines in Genvoya can pass into your breast milk.
Talk with your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines may interact with Genvoya. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
You can ask your healthcare provider or pharmacist for a list of medicines that interact with Genvoya.
Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Genvoya with other medicines.
Genvoya side effects
Genvoya may cause serious side effects, including:
Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (buffalo hump), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines.
Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start, and during treatment.
Your healthcare provider may tell you to stop treatment if you develop new or worse kidney problems.
Bone problems. May include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones.
The most common side effect is nausea.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Source: drugs.com
